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RECRUITING
NCT06488495
NA

Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

1.objective Evaluation of effectiveness and safety of exercise intervention program for patients with non-tuberculous mycobacterial pulmonary disease 2. background Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic respiratory infection that generally affects individuals with structural lung diseases, such as chronic obstructive pulmonary disease (COPD) and bronchiectasis and without structural lung disease. The prevalence of NTM-PD is increasing worldwide , which has caused public health concerns because of environmental exposure to nontuberculous mycobacteria (NTM) and chronic intractable diseases. Pulmonary rehabilitation is essential to the non-pharmacological treatment of chronic respiratory diseases. Positive effects of exercise training have been demonstrated in COPD and bronchiectasis. However, there are limited data on the effectiveness and safety of exercise program for patients with non-tuberculous mycobacterial pulmonary disease 3. design 1\) Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group 1. arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization. 2. arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization. 5\. intervention 1\) 6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants : 1\) patients with nontuberculous mycobacterial pulmonary disease * 40-80 years old * culture positive within 6months * with respiratory symptoms 7. Outcome measure 1. primary outcome : Oxygen uptake max 2. secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker

Official title: A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-07-24

Completion Date

2027-04-01

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Exercise Program

The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.

BEHAVIORAL

Exercise Program

The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea